HUMIRA is indicated for:¹

• In combination with methotrexate (MTX), reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis (JIA) in patients, 2 years of age and older who have had an inadequate response to one or more disease-modifying antirheumatic drugs (DMARDs). HUMIRA can be used as monotherapy in case of intolerance to MTX or when continued treatment with MTX is not appropriate. HUMIRA has not been studied in pediatric patients with polyarticular JIA aged less than 2 years.
• Reducing the signs and symptoms and inducing and maintaining clinical remission in pediatric patients 13 to 17 years of age weighing ≥40 kg with severely active Crohn’s disease (CD) and/or who have had an inadequate response or were intolerant to conventional therapy (a corticosteroid and/or aminosalicylate and/or an immunosuppressant) and/or a tumour necrosis factor (TNF)-alpha antagonist.
• Reducing the signs and symptoms in adult patients with active ankylosing spondylitis (AS) who have had an inadequate response to conventional therapy.
• Reducing the signs and symptoms, inducing major clinical response and clinical remission, inhibiting the progression of structural damage and improving physical function in adult patients with moderately to severely active rheumatoid arthritis (RA). Can be used alone or in combination with MTX or other DMARDs. When used as first-line treatment in recently diagnosed patients who have not been previously treated with MTX, HUMIRA should be given in combination with MTX. Can be given as monotherapy in case of intolerance to MTX or when treatment with MTX is contraindicated.
• Reducing the signs and symptoms of active arthritis and inhibiting the progression of structural damage and improving the physical function in adult psoriatic arthritis (PsA) patients. Can be used in combination with MTX in patients who do not respond adequately to MTX alone.
• Reducing the signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active CD who have had an inadequate response to conventional therapy, including corticosteroids and/or immunosuppressants. HUMIRA is indicated for reducing the signs and symptoms and inducing clinical remission in these patients if they have also lost response to or are intolerant to infliximab.
• Treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response to conventional therapy including corticosteroids and/or azathioprine or 6-mercaptopurine (6-MP) or who are intolerant to such therapies. The efficacy of HUMIRA in patients who have lost response to or were intolerant to TNF blockers has not been established.
• Inducing and maintaining clinical remission in pediatric patients 5 years of age and older with moderately to severely active UC who have had an inadequate response to conventional therapy including corticosteroids and/or azathioprine or 6-MP or who are intolerant to such therapies.
• Treatment of adult patients with chronic moderate to severe plaque psoriasis (Ps) who are candidates for systemic therapy. For patients with chronic moderate plaque Ps, HUMIRA should be used after phototherapy has been shown to be ineffective or inappropriate.
• Treatment of active moderate to severe hidradenitis suppurativa (HS) in adult and adolescent patients (12 to 17 years of age weighing ≥30 kg) who have not responded to conventional therapy (including systemic antibiotics).
• Treatment of non-infectious uveitis (UV) (intermediate, posterior, and panuveitis) in adult patients with inadequate response to corticosteroids or as corticosteroid sparing treatment in corticosteroid-dependent patients.
• Treatment of chronic non-infectious anterior UV in pediatric patients from 2 years of age who have had an inadequate response to or are intolerant to conventional therapy, or in whom conventional therapy is inappropriate.

Clinical use

HUMIRA has not been studied in patients with polyarticular JIA less than 2 years of age or in pediatric patients with a weight below 10 kg.

The safety and efficacy of HUMIRA were authorized in pediatric patients 13 to 17 years of age weighing ≥40 kg with severely active CD and/or who have had an inadequate response or were intolerant to conventional therapy.

There are no clinical trials with HUMIRA in adolescent patients with HS.

HUMIRA has not been studied in pediatric patients with UV less than 2 years of age. Very limited data are available for pediatric patients with UV between 2 and <3 years of age.

HUMIRA has not been studied in pediatric patients with UC less than 5 years of age.

Contraindications

• Severe infections such as sepsis, tuberculosis (TB) and opportunistic infections
• Moderate to severe heart failure (NYHA class III/IV)

Most serious warnings and precautions

Hepatosplenic T-Cell Lymphoma (HSTCL): Very rare post-marketing reports of HSTCL, a rare aggressive lymphoma that is often fatal, have been reported. The potential risk with the combination of azathioprine or 6-mercaptopurine (6-MP) and HUMIRA should be carefully considered.
Infections: Serious infections and hospitalization or fatal outcomes associated with infections have been reported. Treatment with HUMIRA should not be initiated in patients with active infections. In patients who have been exposed to TB, and patients who have traveled in areas of high risk of TB or endemic mycoses, the risks and benefits of treatment with HUMIRA should be considered prior to initiating therapy. Patients should be monitored closely for infections before, during and after treatment with HUMIRA. Administration of HUMIRA should be discontinued if a patient develops a serious infection or sepsis, and appropriate therapy should be initiated. Physicians should exercise caution when considering the use of HUMIRA in patients with a history of recurrent infection or with underlying conditions which may predispose them to infections, or patients who have resided in regions where TB and histoplasmosis are endemic.
Pediatric Malignancy: Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, including HUMIRA.

Other relevant warnings and precautions

For more information

Consult the Product Monograph at abbvie.ca/content/dam/abbviecorp/ca/en/docs/HUMIRA_PM_EN.pdf for important information relating to adverse reactions, drug interactions, and dosing information which have not been discussed in this piece. The Product Monograph is also available by calling us at 1-866-8HUMIRA (1-866-848-6472).